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NCT07456852 · ClinicalTrials.gov registry record · Phase 1
Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy
A Phase 1 study, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT07456852: Recruiting Phase 1 study, sponsored by Mayo Clinic.
NCT07456852 is a Phase 1 study that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07456852, a Phase 1 study, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This phase I/II trial compares the effect of drugs that causes widening of blood vessels as a result of smooth muscle relaxation (vasodilator therapy) with isosorbide mononitrate, diltiazem or placebo to reduce vasotoxicity in patients with gastrointestinal cancer receiving fluoropyrimidine therapy. Some patients develop chest pain (possibly even a heart attack, a drop in heart function, or a rhythm abnormality) during treatment with a class of cancer drugs known as fluoropyrimidines, which include 5-Fluorouracil (5-FU) and capecitabine. These side effects are believed to be due to the development of an abnormal reactivity of the blood vessels referred to as vasospasm. Vasotoxicity is damage or toxicity inflicted upon blood vessels (vascular system), often causing dysfunction, remodeling, or narrowing (vasoconstriction). It is a broad term used to describe the detrimental effects of certain agents, such as chemotherapy drugs. Researchers want to evaluate how often the reactivity of blood vessels becomes abnormal, during the treatment with 5-FU or capecitabine and how clinically relevant and controllable/preventable this phenomenon is in patients with gastrointestinal cancer.
Primary Outcome
Will be analyzed as a continuous variable and paired t-test or Wilcoxon signed-rank test will be used depending on parametric or non-parametric distribution of RHI values. Statistical significance is set at a p-value \< 0.05.
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Capecitabine
- DRUG Fluorouracil
- PROCEDURE Electrocardiogram
- DRUG Diltiazem Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-04-30 |
| Est. Completion | 2030-04-30 |
| Phase | Phase 1 |
What NCT07456852 shows while recruiting
NCT07456852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07456852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07456852 about?
NCT07456852 is a clinical study titled "Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy". This phase I/II trial compares the effect of drugs that causes widening of blood vessels as a result of smooth muscle relaxation (vasodilator therapy) with isosorbide mononitrate, diltiazem or placebo to reduce vasotoxicity in patients with gastrointestinal cancer receiving fluoropyrimidine therapy....
What is the current status of trial NCT07456852?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-04-30. Estimated completion is 2030-04-30.
What interventions are being tested in trial NCT07456852?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Capecitabine (DRUG), Fluorouracil (DRUG), Electrocardiogram (PROCEDURE), Diltiazem Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT07456852?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07456852's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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